FDA EIR - Pace Analytical Life Sciences - September 12, 2019

Bio-Concept Laboratories, Inc. underwent a focused FDA inspection from September 10-12, 2019, prompted by an FDA complaint. As a manufacturer of clinical drugs for human use and a control testing laboratory, the inspection evaluated the firm's Quality and Facilities and Equipment systems.

Key issues identified included a trend of millipede infestations in non-classified areas adjacent to cleanrooms, leading to an undocumented and unauthorized pesticide application inside the facility. A critical violation was the lack of documented management decisions to authorize manufacturing after this breach and pesticide use, with some key personnel unaware of the pesticide application. Consequently, a batch of clinical drug product manufactured during this period was ultimately rejected.

Additional concerns involved inadequate facility maintenance, specifically a pool of liquid and debris in a mechanical space near a classified preparation room, which could foster pests and microbial growth. The regulatory framework of Current Good Manufacturing Practices (CGMP) underscored the firm's responsibility to ensure product quality before release, a point clarified by the FDA.

The company committed to implementing quality systems for documenting management decisions, improving facility maintenance and environmental monitoring programs, and re-evaluating drug product disposition procedures to ensure full CGMP compliance. The firm also updated its pest control procedure to explicitly prohibit internal pesticide application. No Form FDA 483 was issued, indicating verbal observations and commitments for corrective action.